Lamivudine Mylan 300mg film-coated Tablets

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

LAMIVUDINE

Dostępny od:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Kod ATC:

J05AF05

INN (International Nazwa):

LAMIVUDINE 300 mg

Forma farmaceutyczna:

FILM-COATED TABLET

Skład:

LAMIVUDINE 300 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTIVIRALS FOR SYSTEMIC USE

Status autoryzacji:

Withdrawn

Data autoryzacji:

2013-04-29

Ulotka dla pacjenta

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMIVUDINE MYLAN 150 MG FILM-COATED TABLETS
LAMIVUDINE MYLAN 300 MG FILM-COATED TABLETS
lamivudine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lamivudine Mylan is and what it is used for
2.
What you need to know before you take Lamivudine Mylan
3.
How to take Lamivudine Mylan
4.
Possible side effects
5.
How to store Lamivudine Mylan
6.
Contents of the pack and other information
1.
WHAT LAMIVUDINE MYLAN IS AND WHAT IT IS USED FOR
Lamivudine Mylan is used to treat HIV (human immunodeficiency virus)
infection in adults and
children.
Lamivudine Mylan belongs to a group of antiviral medicines, also known
as antiretrovirals, called
nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Lamivudine Mylan does not completely cure HIV infection; it reduces
the amount of virus in your
body, and keeps it at a low level. It also increases CD4 cell count in
your blood. CD4 cells are a
type of white blood cell that are important in maintaining a healthy
immune system to help fight
infection.
Response to treatment with lamivudine varies between patients. Your
doctor will be monitoring the
effectiveness of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE MYLAN
DO NOT TAKE LAMIVUDINE MYLAN:

if you are allergic to lamivudine or any of the other ingredients of
this medicine (listed in section
6)
CHECK WITH YOUR DOCTOR
if you think this applies to you
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WARNINGS AND PRECAUTIONS
Talk to you

Charakterystyka produktu

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Lamivudine Mylan 150 mg Film-coated Tablets
Lamivudine Mylan 300 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 150 mg film-coated tablet contains 150 mg of lamivudine.
Each 300 mg film-coated tablet contains 300 mg of lamivudine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, capsule shaped, biconvex film-coated tablet,
debossed with “M105” on one side
and a functional scoreline on the other.
[For 150 mg only] The tablet can be divided into equal doses.
White to off-white, oval shaped, biconvex film-coated tablet, debossed
with “M300” on one side
and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine Mylan is indicated as part of antiretroviral combination
therapy for the treatment of
Human Immunodeficiency Virus (HIV) infected adults and children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
_Adults, adolescents and children (weighing at least 25 kg)_
The recommended dose of Lamivudine Mylan is 300 mg daily. This may be
administered as either
150 mg twice daily or 300 mg once daily (see section 4.4).
[For 300 mg only] The 300 mg tablet is only suitable for the once a
day regimen.
[For 150 mg only]
_Children (weighing less than 25 kg) _
Dosing according to weight bands is recommended for lamivudine
tablets.
_Children weighing ≥ 20 kg to < 25 kg_
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The recommended dose is 225 mg daily. This may be administered as
either 75 mg (one-half of a
150 mg tablet) taken in the morning and 150 mg (one whole 150 mg
tablet) taken in the evening, or
225 mg (one and a half 150 mg tablets) taken once daily.
_Children weighing 14 to <20 kg _
The recommended dose is 150 mg daily. This may be administered as 75
mg (one-half of a 150 mg
tablet) taken twice daily, or 150 mg (one whole 150 mg tablet) t